Malignant Pleural Effusion Clinical Trial
Official title:
A Prospective, Multicenter, Randomized Controlled Clinical Trial of Bevacizumab in the Treatment of Malignant Pleural Effusions of Non-squamous Non-small Cell Lung Cancer
The purpose of this study is to explore the efficacy and safety of different doses of bevacizumab injection in the treatment of malignant pleural effusion in patients with advanced non-squamous non-small cell lung cancer.
This study is a prospective, multicenter, randomized, phase II clinical study. 87 patients
will be recruited.
Group A (low dose group)
Intrapleural injection of bevacizumab 2.5mg/kg/times, d1, d8; 21 days for a course of
treatment. Subjects will received two courses of treatment if there is no termination of
treatment listed in the standard.
Group B (medium dose group)
Intrapleural injection of bevacizumab 5mg/kg/times, d1, d8; 21 days for a course of
treatment. Subjects will received two courses of treatment if there is no termination of
treatment listed in the standard.
Group C (high dose group)
Intrapleural injection of bevacizumab 7.5mg/kg/times, d1, d8; 21 days for a course of
treatment. Subjects will received two courses of treatment if there is no termination of
treatment listed in the standard.
Main evaluation criteria: pleural effusion objective response rate(ORR) (WHO standard)
Secondary evaluation criteria: pleural fluid time to progression (TTP), overall survival
(OS), ORR, QOL scores (Quality of Life Questionnaire-lung cancer) and KPS, and safety (NCI
CTCAE V4.03)
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